510(k) · Cleared
Recalled · Class II · 2018Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Mar 24, 2008 as substantially equivalent to K052707 (Philips Medical Systems, 2005) after a 31-day review. Its family tree reaches back 6 generations to 1994. 18 later devices descend from it. It has been recalled once.
- Decided
- Mar 24, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941811 (1994). 23 ancestors in all, the oldest K903523 (1990). 18 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 1 generation backK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005 · Recalled
- This deviceK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008
- Descendant · cites it directly · 11 of its ownK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- Descendant · cites it directly · 7 of its ownK101067 Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064…Philips Medical Systems · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK120132 Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012
- Descendant · cites it directly · 6 of its ownK103652 Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6…Philips Medical Systesms · 2011
- Descendant · cites it directly · 5 of its ownK123900 Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…Philips Medical Systems North America Co. · 2008 · cites it directly11descendants
- K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Philips Medical Systems · 2010 · cites it directly7descendants
- K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012 · 2 generations on6descendants
- K103652Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8Philips Medical Systesms · 2011 · cites it directly6descendants
- K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −1 | K052707 | M3046B Compact Portable Patient Monitors | Philips Medical Systems | 2005 | 1 |
| 0 (this device) | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 | Philips Medical Systems | 2008 | — |
| +1 | K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns… | Philips Medical Systems North America Co. | 2008 | — |
| +1 | K101067 | Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065… | Philips Medical Systems | 2010 | 1 |
| +2 | K120132 | Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor | Philips Medical Systems | 2012 | — |
| +1 | K103652 | Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and… | Philips Medical Systesms | 2011 | — |
| +1 | K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | Philips Medical Systems | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052707 | M3046B Compact Portable Patient MonitorsSummary page 1…6. The modified devices are substantially equivalent to previously cleared Philips device, M3046B Compact Configurable Portable Patient Monitor marketed pursuant to K052707. February 10, 2008… | 2005 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital… | 2008 | 11 |
| K101067 | Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 | 2010 | 7 |
| K103652 | Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8 | 2011 | 6 |
| K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | 2013 | 5 |
| K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2018 | Class II | Z-2895-2018 | Labeling design | Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K082280 (Philips Medical Systems North America Co., 2008) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K052707.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080495 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080495
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026